A Study to Establish the Diagnostic Value of the EPISEEK-MPE Liquid Biopsy Assay to Identify Cancer in Pleural Effusion Samples. (EPISEEK-MPE)
Development of a Molecular Assay to Diagnose Malignant Pleural Effusions
The goal of this study is to evaluate the EPISEEK-MPE laboratory test for diagnosis of malignant (cancerous) pleural effusions verses pleural effusions caused by a non-cancer condition. The study uses excess samples drained from around the lung as part of a patient's regular care. The main questions the study aims to answer are:
- Is the EPISEEK-MPE test reliable to detect cancer cells and aid in the diagnosis of malignant pleural effusions?
- Do age, race, gender and ethnicity change the reliability of the EPISEEK-MPE test?
- Can the results of the EPISEEK-MPE test predict which patients have a better chance of survival than others?
Participants will be asked to donate a small portion of the excess fluid drained from around the lung for research. Participants will also give permission to collect data from the medical records.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
In clinical practice, it remains a challenge to distinguish between malignant pleural effusion (MPE) and benign pleural effusion (BPE). Because of the limitations of conventional cytology methods, there is an urgent need to develop a more accurate and effective method for the efficient diagnosis of MPE. In collaboration with the University of Arizona, Precision Epigenomics has developed the EPISEEK-MPE test that has the potential to be an effective complimentary tool for cytology in the process of differential diagnosis. The aim of this project is to conduct a multi-site clinical validation study to establish the EPISEEK-MPE test as a new commercial molecular test for the diagnosis of malignant pleural effusions. The study will: 1) Establish the diagnostic value of the EPISEEK_MPE liquid biopsy assay to identify cancer in pleural effusion and 2) Validate the EPISEEK-MPE liquid biopsy assay for cancer detection in pleural effusion. The long-term goal of this project is to bring the field of pathology a new diagnostic tool for the diagnosis of malignant pleural effusions.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Arizona
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Tucson, Arizona, Forente stater, 85713
- Rekruttering
- Banner University Medical Center South
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Ta kontakt med:
- Trina Hughes
- Telefonnummer: 520-626-9372
- E-post: tdhughes@arizona.edu
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Tucson, Arizona, Forente stater, 85719
- Rekruttering
- Banner University Medical Center Tucson
-
Ta kontakt med:
- Trina Hughes
- Telefonnummer: 520-626-9372
- E-post: tdhughes@arizona.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Adult patients that are having pleural fluid drained as part of clinical care.
Beskrivelse
Inclusion Criteria:
- Adult patients having pleural fluid drained for clinical care (thoracentesis or chest tube placement)
- Consent to have pleural fluid sample used for research
Exclusion Criteria:
- Insufficient fluid available following clinical drainage procedure
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Benign pleural effusions
Patients with pleural effusions due to infection, heart failure, atelectasis, bronchial obstruction, pulmonary embolism, etc. To be included in the benign group, subjects cannot have any cancer-related history within the last 15 years and chest radiograph will be without evidence of lung mass / malignancy. |
|
Indeterminate pleural effusions
Patients with a known cancer diagnosis, but with cytology negative pleural fluid. |
|
Malignant pleural effusions
Patients with known cancer and a cytology positive pleural fluid sample. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic performance
Tidsramme: From enrollment to the completion of the study analysis an average of 2 years
|
To determine the diagnostic performance characteristics of the EPISEEK-MPE test in terms of accuracy, specificity, sensitivity, negative predictive value (NPV), and positive predictive value (PPV). |
From enrollment to the completion of the study analysis an average of 2 years
|
|
Predictive value
Tidsramme: From enrollment to 1 year post procedure
|
Investigators will evaluate the association of the methylation signal from the EPISEEK-MPE test with overall survival. |
From enrollment to 1 year post procedure
|
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Validate EPISEEK-MPE
Tidsramme: From enrollment to the completion of the study analysis
|
Establish the performance specifications of EPISEEK-MPE as a laboratory developed test including:
|
From enrollment to the completion of the study analysis
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Methylation signal
Tidsramme: At baseline
|
Determine the methylation signal relationship with clinical variables such as age, race, gender, and ethnicity. |
At baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB # 2012283169
- 1R44CA287829-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
This is an exploratory study with a commercial entity and data is considered joint intellectual property.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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